MAUDE Adverse Event Report: HOLGER ULLRICH MEERA ST EU WITH AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B2

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

No malfunction of the product was reported by the customer.The incident was caused by a user error.In the instructions for use (ifu) it is stated the user has to pay attention and avoid collisions when operating the table.In chapter 2 of the ifu possible hazards are stated: "warning! risk of injury! when adjusting and moving the or table, the table top or the accessories, collisions may occur with the patient, between the individual products or parts pointing downwards.During the adjustment procedures, always pay attention to the or table and accessories and avoid collisions.Ensure that tubes, cables and drapes are not trapped." maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.The full event site name is "(b)(6)".The event site phone number is (b)(6).

Event Description

The following was reported.The operating tables (or table) downward movement was blocked by an instrument table.When the or table was lowered, one side of the tables base was lifted, since the downward movement was blocked.When the or table was moved upwards again, the lifted table base came down and crushed a doctors foot.The injured foot was examined.It was reported that no bone fracture occurred.The injury was described as "only slightly crushed".No delay of the surgical procedure occurred due to this issue.Manufacturer reference # (b)(4).

• Brand Name: MEERA ST EU WITH AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 10777115
• MDR Text Key: 214304790
• Report Number: 8010652-2020-00023
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other